Early Extubation and Postoperative Complications After Liver Transplantation

Completed

• Conditions: Liver Transplantation
• Interventions: Procedure: extubation in the ICU; Procedure: extubation in the operating room

• Registration Number: NCT04261816
• Lead Sponsor: West China Hospital

Brief Summary

This is a retrospective cohort study. Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study and divided into two groups. Operating room extubation group: early extubation in the operating room immediately following liver transplantation. Intensive care unit (ICU) extubation group: delay extubation in the ICU following liver transplantation. The primary objectives were to compare the incidence of composite outcome between the two groups. secondary objectives were to compare outcomes such as length of stay, hospital length of stay, and total cost between the two groups.

Detailed Description

Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study. Inclusion criteria: (1) adult patients (age ≥ 18 years), (2) undergoing liver transplantation. Exclusion criteria were the following: (1) re-transplantation; (2) multi-visceral transplantation; (3) intraoperative death; (4) severe encephalopathy (West Haven criteria III or IV); (5) those who had preoperative mechanical ventilation; (6) incomplete clinical data. The primary objectives was a composite of 30-day all-cause mortality, in-hospital AKI, or in-hospital moderate to severe pulmonary complications. Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions and were included if they occurred in hospital after surgery. The secondary objectives included in-hospital moderate to severe infectious complications, unplanned reintubation rates, ICU and postoperative hospital lengths of stay, and total hospital cost.

Study Timeline

• Study Start: 2020-01-15
• Study First Submitted: 2020-02-01
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-10
• Primary Completion: 2020-04-15
• Study Completion: 2020-04-15
• Status Verified: 2021-04
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 438

Inclusion Criteria

• Adult patients (age ≥ 18 years)
• Undergoing liver transplantation

Exclusion Criteria

• Re-transplantation
• Multi-organ transplants
• Intra-operative deaths
• severe encephalopathy (West Haven criteria III or IV)
• patients who had preoperative mechanical ventilation or fulminant hepatic failure
• Incomplete clinical data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU extubation group	extubation in the ICU	extubation in the ICU following liver transplantation
Operating room extubation group	extubation in the operating room	extubation in the operating room immediately following liver transplantation

Primary Outcome Measures

Name	Time	Method
The incidence of a composite of 30-day all-cause mortality, AKI and moderate to severe pulmonary complications.	through study completion, an average of 1 year	Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions and were included if they occurred in hospital after surgery

Secondary Outcome Measures

Name	Time	Method
The incidence of moderate to severe infectious complications	30 days	Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions and were included if they occurred in hospital after surgery
The length of ICU stay	through study completion, an average of 1 year	Length of ICU stay is the duration of a single episode of ICU hospitalization
The incidence of re-intubation.	30 days	Reintubation was defined as intubation after extubation of a patient who had been initially tracheal intubated under general anaesthesia
The length of hospital stay	through study completion, an average of 1 year	Length of hospital stay is the duration of a single episode of hospitalization
The total hospital cost	30 days	The total hospital cost

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China